ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- June 29, 2015
- Posted
- August 7, 2015
- Terminated
- October 26, 2015
- Recall Number
- Z-2352-2015
- Quantity
- 950
- Firm Location
- South Jordan, UT
Reason for Recall
Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the Merit ReSolve Drainage Catheters and the actual device in the package.
Distribution
Nationwide Distribution including the Virgin Islands.
Lot / Code Info
Lot No: E796578 E796579 MR792035 MR786325 MR797946 MR791206 MR791212 MR786923 E796605 MR786311 MR791660 E796647 RL MR795466 MR786301 E796629 E796631 E796636 E796637 MR786306 MR786320 MR786318 MR786319
Root Cause
Employee error
Action Taken
Merit Medical Systems sent an Urgent Product Recall Notice dated July 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions required of you: 1. Please immediately determine if any of the devices are within your facility, quarantine them, and discontinue use. Due to the nature of this label discrepancy, you will need to physically verify whether product in inventory is within the scope of this recall. Your Merit Sales Representative can assist you with this determination. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Please work with your Merit Sales Representative to arrange product return. 4. If you have any questions concerning this communication, please don't hesitate to contact your Merit Sales Representative or call (801)208-4365.